Safety and Tolerability Evaluation Study of BVAC-B in Patients With HER2/Neu(Human Epithelial Growth Factor Receptor 2) Positive Gastric Cancer After Failure to Standard Care

NCT03425773 | Completed Phase 1

• 1 other identifier: BVAC-B-P1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

BVAC-B is immunotherapeutic vaccine using B-Cell and Monocytes as antigen presenting cell. This study is Open-label, Accelerated titration, Multiple dosing study to evaluate the safety, tolerability, immune response and pre-efficacy of BVAC-B in patients with progressive or recurrent HER2/neu positive gastric cancer after failure to standard care. 9-27 patients will be enrolled.

Conditions

Stomach Neoplasms

Keywords

HER2/neu; IHC 1+; BVAC; Cellid; B-cell; Monocyte; Immunotherapeutic vaccine; Breast cancer; Colorectal cancer; Pancreatic cancer

Outcome Measures

Primary Outcomes (2)

• Evaluate Maximum tolerated dose(MTD) for phase 2 trial

  Find Serious adverse drug reaction(Grade 3)

  End of Dose-escalation stage(7 month from study start, Estimated)

• Incidence of Serious Adverse Events assessed with CTCAE v4.03

  Evaluate safety and tolerability

  14th week from first injection

Secondary Outcomes (6)

• Serum cytokine

  Screening visit, Visit 2 (0 week) , visit 4 (4 week) ,visit 5 (6 week), visit 6 (8 week), visit 8(12 week), Termination visit(16 week)

• HER2/neu specific antibody

  Screening visit, every 2 weeks after 1st injection(till 16th week)

• NKT/NK cell assay

  Screening visit, every 24hr after injection(up to 12th week)

• CD4/CD8 assay

  Screening visit, every 2 weeks after 1st injection(up to 16th week)

• Lymphocyte subset

  Screening visit, visit 4 (4 week), visit 6 (8 week), visit 8 (12 week), termination visit (16 week)

Study Arms (1)

BVAC-B

EXPERIMENTAL

BVAC-B IV injection at 0, 4, 8, 12nd weeks.

Biological: BVAC-B

Interventions

BVAC-B BIOLOGICAL

Autologous B cell and monocyte presenting HER2/neu antigen

BVAC-B

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Progressive or recurrent HER2/neu positive(IHC 1+≥) gastric cancer
• Received 1 or more chemotherapy or radiotherapy as prior therapy for progressive or recurrent tumor lesion
• At least 1 measurable lesion according to RECIST(ver 1.1)
• Ages above 19
• ECOG performance status between 0 to 2
• Patients meets the blood test standards in the screening test
• Patients meets the blood chemistry test standards in the screening test
• Patients who has agreed to a medically accepted contraceptive in this clinical trial
• Patients at least six months or more of survival can be expected
• Patients decided to participate in this clinical trial and signed written informed consent

You may not qualify if:

• Histopathology is a neuroendocrine or small cell carcinoma
• History of brain metastasis or signs of brain metastasis
• Clinical diagnosis of hepatitis C or hepatitis B
• Clinical diagnosis of human immunodeficiency virus (HIV)
• History of HIV infection
• Patients with heart failure, coronary artery disease(CAD) or Myocardial infarction in 6 month prior to screening. (LVEF is lower than 50% in screening visit)
• Administered the drug for other clinical trials within 4weeks before participate in this trial
• Administered any vaccines within 4weeks before participate in this trial (4 weeks for live vaccine, 2 weeks for other inactivated vaccine)
• Administered the granulocytes concentrates within 3 months before the screening visit
• Received chemotherapy or radiation therapy within 2 weeks before the 1st administration of investigational drug(BVAC-B)
• Received following formulation within 1 months before the screening visit : Chronic steroids(more than 5 days), immunosuppressant or immunomodulatory agents. G-CSF
• Patients who have participated in the clinical trial of a immunotherapeutic vaccine within 1 year or immunotherapy within 3 months before the screening visit
• Patients who is pregnant or breast-feeding
• Patients who researchers has determined that participation in the clinical trial is inappropriate
• Suspected to have other progressive cancer or malignant tumor needs treatment in 3 years. Completely treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, thyroid carcinoma, cervical intraepithelial neoplasia are not included

Sponsors & Collaborators

• Cellid Co., Ltd.: lead

Study Sites (1)

Severance Hospital

Seoul, Seodaemun-gu, 03722, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Accelerated titration

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 8, 2018
• Study Start: February 26, 2018
• Primary Completion: May 13, 2019
• Study Completion: May 13, 2019
• Last Updated: February 20, 2020

Record last verified: 2020-02

Locations

KR (1)